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| Sponsor: | Morphotek |
|---|---|
| Information provided by (Responsible Party): | Morphotek |
| ClinicalTrials.gov Identifier: | NCT00738699 |
Purpose
The study is being conducted to find out if paclitaxel works better when given together with an experimental drug called MORAb-003(farletuzumab) or alone in patients with platinum-resistant or refractory relapsed ovarian cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: MORAb-003 (farletuzumab) Drug: 0.9% Saline |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double Blind, Placebo-Controlled Study of the Efficacy and Safety oF MORAb-003(Farletuzumab)in Combination With Paclitaxel Therapy in Subjects With Platinum-Resistant or Refractory Relapsed Ovarian Cancer |
| Estimated Enrollment: | 550 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Paclitaxel with MORAb-003(farletuzumab)
|
Drug: MORAb-003 (farletuzumab)
2.5mg/kg IV day 1 weeks 1-12 (cycle 1); day 1 weeks 1-3 with week 4 as rest week for subsequent cycles
|
|
Placebo Comparator: 2
Paclitaxel with Placebo
|
Drug: 0.9% Saline
2.5mg/kg IV day 1 weeks 1-12 (cycle 1); day 1 weeks 1-3 with week 4 as rest week for subsequent cycles
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Clinical contraindications to use of paclitaxel, which include:
Contacts and Locations
Show 61 Study Locations
More Information
| Responsible Party: | Morphotek |
| ClinicalTrials.gov Identifier: | NCT00738699 History of Changes |
| Other Study ID Numbers: | MORAb003-003PR |
| Study First Received: | August 18, 2008 |
| Last Updated: | December 5, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
ovarian cancer relapsed ovarian cancer refractory ovarian cancer |
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |